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EP-4157147-B1 - HYDRAULIC DELIVERY OF SURGICAL IMPLANTS

EP4157147B1EP 4157147 B1EP4157147 B1EP 4157147B1EP-4157147-B1

Inventors

  • LEE, IV, Jestwin Edwin
  • JENSEN, Kathryn
  • PIAZZA, MICHAEL
  • TABER, Todd
  • YADAV, SAUMYA DILIP
  • MAGADUM, PRADEEP
  • RODEHEAVER, AUSTIN XAVIER

Dates

Publication Date
20260506
Application Date
20210601

Claims (15)

  1. An actuator apparatus (115) for advancing a lens in an implant delivery system (100), the apparatus comprising: a housing (215) comprising a plunger interface (305), a drive interface (230), and a bypass channel (310) disposed between the plunger interface and the drive interface (230); a plunger (220) disposed within the housing, the plunger having a first end (315) adjacent to the plunger interface, a second end (320), and a bore (225) between the first end and the second end; a plunger seal (235) disposed within the housing and coupled to the second end of the plunger; a drive seal (240) disposed within the housing between the plunger seal and the drive interface; and a fluid chamber (250) defined within the housing between the plunger seal and the drive seal; wherein the plunger (220), the plunger seal (235), and the drive seal (240) are movable within the housing between a first position in which the plunger seal (235) fluidly isolates the bore (225) from the fluid chamber (250) and a second position in which the bypass channel (310) fluidly couples the bore (225) to the fluid chamber (250) around the plunger seal (235).
  2. The apparatus of claim 1, wherein the drive seal (240) is movable to a third position to move fluid from the fluid chamber through the bypass channel (310) and the bore (225).
  3. The apparatus of claim 1, further comprising: a nozzle seal (325) disposed proximate to the first end (315) of the plunger; and a bypass seal (330) configured to be disposed between the nozzle seal (325) and the bypass channel (310) in the second position.
  4. The apparatus of claim 3, wherein the nozzle seal (325) is arranged according to one of the following: (i) wherein the nozzle seal (325) comprises a first ring seal and the bypass seal comprises a second ring seal; (ii) wherein the nozzle seal (325) comprises an umbrella seal.
  5. The apparatus of any preceding claim, further comprising a lens interface coupled to the first end (315) of the plunger (220).
  6. The apparatus of any preceding claim wherein the first end (315) of the plunger (220) is configured to move through the plunger interface (305).
  7. The apparatus of any preceding claim, wherein the bypass channel (310) comprises a plurality of channels disposed circumferentially around the housing.
  8. The apparatus of any preceding claim, wherein the housing (215) further comprises a priming channel (1205) configured to fluidly couple the bore (225) to the fluid chamber (250) between the first position and the second position.
  9. The apparatus of claim 8, wherein the priming channel (1205) has a lower flow rate than the bypass channel.
  10. The apparatus of any preceding claim, wherein the drive interface (230) is configured to receive a push rod (245) for engaging the drive seal within the housing.
  11. The apparatus of any preceding claim, further comprising a fluid disposed in the fluid chamber.
  12. The apparatus of any preceding claim, further comprising: a push rod (245) configured to engage the drive seal through the drive interface.
  13. A system (100) for implanting a lens into an eye, the system comprising: a nozzle (105) having a delivery lumen; an implant bay (110) coupled to the nozzle; and an actuator (115) as claimed in any of claims 1-12 comprising a housing (215), a plunger (220) disposed within the housing (215) and operable to move from a first position to a second position to advance the lens from the implant bay (110) to the delivery lumen (205), a bore (225) fluidly coupled to the delivery lumen through the plunger and the implant bay, a fluid chamber, and a bypass channel; wherein the bore (225) is fluidly isolated from the fluid chamber (250) in the first position and is fluidly coupled to the fluid chamber through the bypass channel (310) in the second position.
  14. The system of claim 13, wherein the actuator (115) is arranged according to one or more of the following: (i) wherein the actuator (115) is configured to move fluid from the fluid chamber (250) to the delivery lumen through the bypass channel (310) and the bore (225) in the second position; (ii) wherein the actuator further comprises a drive seal (240) configured to move fluid from the fluid chamber (250) through the bypass channel (310) and the bore (225) in the second position. (iii) wherein the actuator (115) further comprises a priming channel (1205) configured to fluidly couple the bore (205) to the fluid chamber between the first position and the second position; (iv) wherein the actuator further comprises a priming channel (1205) configured to fluidly couple the bore (225) to the fluid chamber (250) between the first position and the second position and wherein: the bypass channel (310) has a first flow rate; the priming channel (1205) as a second flow rate; and the second flow rate is less than the first flow rate.
  15. The system of any of claims 13-14, wherein: the implant bay (110) comprises an implant management system having an implant chamber; and the plunger (220) is operable to move at least partially through the implant chamber (430) to advance the lens.

Description

TECHNICAL FIELD The invention set forth in the appended claims relates generally to eye surgery. More particularly, but without limitation, the claimed subject matter relates to systems and apparatuses for inserting an implant into an eye. BACKGROUND The human eye can suffer a number of maladies causing mild deterioration to complete loss of vision. While contact lenses and eyeglasses can compensate for some ailments, ophthalmic surgery may be required for others. In some instances, implants may be beneficial or desirable. For example, an intraocular lens may replace a clouded natural lens within an eye to improve vision. While the benefits of intraocular lenses and other implants are known, improvements to delivery systems, components, and processes continue to improve outcomes and benefit patients. Reference is made to US2014/276898 and EP3560457 which have been cited as relating to the state of the art. Particularly, US2014/276898 describes an implant delivery system in which fluid is used to control the movement of a plunger that advances an intraocular lens through a lumen. BRIEF SUMMARY It will be appreciated that the scope is in accordance with the appended claims. Further arrangements not claimed in the appended claims, and outside the scope of the claims, may be included in the specification as background and to assist in understanding the invention. New and useful systems and apparatuses for eye surgery are set forth in the appended claims. Illustrative embodiments are also provided to enable a person skilled in the art to make and use the claimed subject matter. For example, some embodiments provide an apparatus in accordance with claim 1 for delivering an implant using hydraulic pressure or fluid flow. Further optional features are set out in the dependent claims. In more particular examples, an implant may be stored, advanced, and delivered to an eye using hydraulic fluid stored in a sterile container through a hollow advancement plunger. The plunger may rigidly advance the implant to a sealed position in a first phase, and then the implant may be advanced into the eye via hydraulic pressure or fluid flow in a second phase. For example, the plunger may first be used to advance the implant to a point that a seal is created about the implant within a delivery channel. The implant may then be hydraulically advanced to delivery. For example, a delivery fluid can be passed through a bore in the plunger to advance the implant. In some embodiments, an implant interface associated with the plunger may be shaped for engaging a shoulder of the implant for advancement. Such embodiments may be particularly advantageous for delivering intraocular lenses, including accommodating lenses, which can present unique challenges for delivery. For example, an accommodating lens may contain a fluid that can be manipulated by ciliary muscle movement to change the power of the lens. Some embodiments can manage fluid in the accommodating lens to compress a relatively large lens for advancement through an acceptably small incision, manage deformation caused by shifting fluid during compression and exit from a nozzle, and execute delivery in a predictable and controlled manner. An intraocular lens may additionally include one or more haptics, which can extend radially to secure the lens within an eye. Some embodiments can reduce system complexity and the number of delivery steps while maintaining haptic position consistency. Some embodiments may also reduce the amount of working fluid for delivery. More generally, some embodiments may provide an apparatus for advancing a lens in an implant delivery system. The apparatus may comprise a housing having a plunger interface, a drive interface, and a bypass channel disposed between the plunger interface and the drive interface. A plunger may be disposed within the housing, and the plunger may have a first end adjacent to the plunger interface, a second end, and a bore through the plunger between the first end and the second end. A plunger seal may be disposed within the housing and coupled to the second end of the plunger, and a drive seal may be disposed within the housing between the plunger seal and the drive interface. A fluid chamber may be defined within the housing between the plunger seal and the drive seal. The plunger, the plunger seal, and the drive seal are moveable in fixed relation to each other within the housing between a first position and a second position. Generally, the first end of the plunger may be configured to move through the plunger interface. In the first position, the plunger seal can fluidly isolate the bore from the fluid chamber. In the second position, the bypass channel can fluidly couple the bore to the fluid chamber around the plunger seal. In more particular embodiments, the drive seal may be movable to a third position to move fluid from the fluid chamber through the bypass channel and the bore. Some embodiments may further comprise a nozzl